BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH AGT NASAL PERFORMED ET TUBE, 7.0MM

    MDR report key: 3000132 · Received March 8, 2013

    Report

    Report Number
    8040412-2013-00050
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BSK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUFF OF THE ENDOTRACHEAL TUBE LEAKED DURING INTUBATION. THE TUBE WAS REMOVED AND THE PT RE-INTUBATED. THE CUFF OF THE ENDOTRACHEAL TUBE WAS NOT PRE-INFLATED. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98812 RUSCH AGT NASAL PERFORMED ET TUBE, 7.0MM CUFFED ENDOTRACHEAL TUBE BSK TELEFLEX MEDICAL 12JG17

    Patients

    Seq Age Sex Outcome Treatment
    1